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1. Field of Invention
This invention relates to supports which elevate the lower legs of patients with circulatory insufficiency in the lower limbs in order to prevent or relieve pressure ulcers on the heels or feet.
2. Description of Related Art
The incidence of pressure ulcers is sufficiently high as to warrant concern among health care providers. High-risk groups include elderly patients admitted to a hospital for femoral fracture and critical care patients. The prevalence of pressure ulcers in skilled care facilities and nursing homes is reported to be as high as 23 percent.
Successful management of pressure ulcers involves three components; nutritional assessment and support; management of tissue loads; and managing bacterial colonization and infection.
Management of tissue loads, i.e. pressure, friction, and shear, through use of positioning techniques and support surfaces is critical to the treatment of pressure ulcers. It is important that individuals with pressure ulcers who are in bed not be positioned on the pressure ulcers. Positioning devices should be used to raise a heel ulcer off the support service and prevent direct contact between bony prominences. Care should be taken to assure that the patient has not xe2x80x9cbottomed outxe2x80x9d under a pressure ulcer or part of the body at risk for ulcer formation, that is, that there should be at least one inch of support material below that portion of the body.
Because of the small surface area it is difficult to redistribute pressure under the heels and new pressure ulcers often develop on the heels of patients cared for on pressure-reducing devices. Suspension of the heel has been suggested as the best remedy, especially in individuals unable to reposition their lower extremities. Ring cushions have been found to be more likely to cause pressure ulcers than to prevent them. Treatment of Pressure Ulcers, Clinical Guideline Number 15, AHCPR Publication No. 95-0625, December 1994.
The present invention deals with the prevention and management of heel pressure ulcers primarily in two ways. 1. It raises the lower legs with respect to the torso and thereby promotes the circulation of blood through the legs and feet. 2. It suspends the heels and feet above and out of contact with any support surface, thereby preventing the development of pressure ulcers and encouraging the healing of existing pressure ulcers. The present invention also finds additional application in treating post-operative orthopedic patients, and in pre- or post-operative patients with venous insufficiency.
U.S. Pat. No. 2,709,435 discloses a leg rest which supports a leg for the purpose of treating the leg with medical fluids and for collecting the fluids which drain from the leg.
U.S. Pat. No. 3,333,286 discloses an adjustable sick-bed bolster which is wedge shaped and capable of multiple configurations. The bolster can be made of foam rubber or any similar material.
U.S. Pat. No. 3,639,927 discloses a mattress for invalids in which two wedge pieces support the shanks down to the region of the ankles. The heels and feet do not contact the mattress.
U.S. Pat. No. 3,842,977 discloses a pillow-enclosing casing in which a pillow, particularly a foam pillow, is rolled and reduced in volume and then inserted into a tubular casing.
U.S. Pat. No. 4,045,204 discloses a compressed foam article which is compressed and packaged by enclosure in a substantially air-tight sack and a vacuum is drawn in the sack.
U.S. Pat. No. 4,711,067 discloses a method of packaging a mattress to a small size, in which the mattress is squeezed by compression means which drive the air from mattress and is then placed in a closed container or case.
U.S. Pat. No. 5,134,739 discloses a protective device which gives a set position to lower limbs. This involves a central block with side supports for the legs which have a concave shape.
The heels and feet do not touch the device. This device does include provisions for preventing the legs from falling off the device.
U.S. Pat. No. 5,173,979 discloses an inflatable leg and foot supporting cushion. The heels are supported by the cushion. The cushion is covered by a fluid-impermeable material. The cushion may include a lip or be covered with a diaper-like material to contend with fluids from ulcers.
U.S. Pat. No. 5,289,828 discloses a pillow for orthopedic support, especially for support after hip surgery.
U.S. Pat. No. 5,584,303 discloses a therapeutic leg elevator which supports the leg from the ankle to at least the calf which can be configured so that the heel does not contact the foot portion of the support.
U.S. Pat. No. 5,666,682 discloses a foam mattress pad of adjustable width which has a tear strip of foam material to reduce the width of the mattress.
U.S. Pat. No. 5,745,939 discloses a leg rest for supporting a patient on a bed during turning or otherwise managing the patient. There are a pair of trough portions for receiving the patient""s legs and which prevent movement of the patient""s legs.
U.S. Pat. No. 5,878,551 discloses method of packaging a foam pet industry product which involves placing the foam product inside a plastic bag, reducing the pressure to remove fir from the bag, and sealing the bag.
U.S. Pat. No. 5,944,683 discloses a resilient cushion to be positioned on the skin adjacent a bony prominence having a recess for the bony prominence.
U.S. Pat. No. 6,065,166 discloses an inflatable surgical support cushion which includes a concavity formed by side bolster structures.
U.S. Pat. No. 6,085,371 discloses a leg support apparatus which supports a single leg and is made from cardboard, plastics, or wire frames, and are stack able or foldable.
U.S. Pat. No. 6,135,560 discloses a travel headrest pillow shaped to conform to the shape formed by the back of the user""s neck, head and shoulder.
U.S. Pat. No. 6,151,739 discloses a sleep support surface including a mattress with inflatable bladders near the foot end which lift the calves of the patient and reduce pressure on the patient""s heels.
U.S. Pat. No. 6,175,979 discloses an inflatable orthopedic pillow with an area for isolating a patient""s foot as well as provisions for maintaining the foot in a particular position or orientation.
U.S. Pat. No. 6,186,967 discloses a elevation support for a limb which surrounds a limb and has a longitudinal aperture for insertion at least a portion of the limb.
U.S. Pat. No. 6,256,804 discloses a pillow like protector and support device with a central surface having cut-away air gaps forming grooves for supporting various body parts.
U.S. Pat. No. 6,260,221 discloses a heel supporting apparatus which substantially immobilizes the legs and includes a heel pad which supports the heel and an inflatable bladder which contacts the bottom of the feet.
U.S. Pat. No. D311,470 discloses a support cushion with contours which supports a person""s legs and feet.
None of the prior art devices have the characteristics of the present invention, that of elevating and supporting a patients heels and feet to prevent and manage pressure ulcers using an inexpensive cushion which is inexpensive, easy to manufacture and clean, and provides support for the legs while allowing reasonable movement associated with patient treatment.
This application discloses a heel elevator support for stimulating circulation in the lower and upper extremities and for preventing and managing heel pressure ulcers. The invention comprises a rectangular cushion having a front end and a back end, a left and a right side, and a top and bottom surface, the cushion having a width from the left side to the right side approximating the width of a bed, approximately 26 to 36 inches. The cushion having a length from the front end to the back end approximating the length of a patient""s leg from knee to Achilles tendon, approximately 12 to 25 inches. The cushion having from the top surface to the bottom surface a height adequate to stimulate circulation in the lower extremities, approximately 3-6 inches. Two ramparts are integral with the cushion, a first rampart located at the left side and parallel to the left side, and a second rampart located at the right side and parallel to the right side. Each rampart extends above the upper surface of the cushion approximately 1 to 8 inches. Examples of ramparts which are bolsters and palisades are disclosed. The support is comprised of a foam material, and the support is covered by a water-resistant elastomer material.
Pressure ulcers have become a multi million dollar largely preventable problem for the healthcare industry. The incidence of lawsuits due to patient injury has continued to increase exponentially, with the average settlement rising from $250,000 to $450,000 in the past two years. In areas that do not have caps for settlements, this figure has been in the millions of dollars. This is regarded as a sentinel injury.
Heel pressure ulcers in particular are a problem because, due to decreased blood flow, they do not heal quickly. Heel ulcers cause decreased mobility, considerable pain, and can lead to amputation in patients with severe arterial disease.
Venous stasis disease, predisposing to heel pressure ulcers, is a lifetime problem for some patients, necessitating continued control of edema in order to prevent recurrent skin breakdown. Many of these patients also have some degree of arterial insufficiency, which makes leg elevation painful. Because of these factors, noncompliance with prescribed treatment regimens to manage the disease is very high.
Orthopedic patients, particularly patients with lower extremity procedures such as hip surgery, and those with cases, are at extreme risk because of the immobility needed in the immediate post procedure period. Additional immobility sometimes occurs due to pain while in rehab. These patients can experience only the slightest degree of elevation, due to the need for proper joint positioning, which leads to a very high degree of heel pressure and risk of development of heel pressure ulcers. Any such heel injury can cause delays in rehab because of inability to walk on the injured foot or to put a shoe on the injured foot.
Any patient who requires extended periods (greater than 1-2 hours) of limb elevation would benefit from this invention, as it does not require constant repositioning or reapplication. This includes upper extremities, as may occur in patients with lympodema, which often accompanies mastectomy patients. In these cases maintaining proper blood flow to reduce swelling while minimizing pain or joint injury are key in the post operation period. The present invention provides minimum elevation under stable conditions, due to the use of high density foam.
Even the use of pressure relief beds has been shown to result in pressures as high as 25 mmHG on patient""s heels. The present invention eliminates any pressure on the heel.
Elevation of extremities, upper as well as lower, allows increased venous flow without compromising arterial flow. This is particularly beneficial in the treatment and prevention of edema.
The present invention allows for proper positioning of extremities, while allowing for leg and foot mobility, which provides maximum comfort for any patient who must be in bed longer than 2 hours.
The present invention can be used for patients with bed immobility due to any disease process, venous stasis disease, including patients with mixed arterial insufficiency, orthopedic patients who require positioning and pressure ulcer prevention, and in general, any patient whose disease process would benefit from minimal extremity elevation.
The present invention does not require the use of boots. Boots can injure the patient through improper fit, pressure due to hook and loop straps, and the boot slipping into improper position. These problems can cause sever injury to the patient through decreased arterial flow and direct pressure on the skin. The use of boots requires removal and inspection every 2 hours to avoid these problems. The present invention avoids all of these difficulties.
The present invention avoids patient injury due to waffle type foam. Such foam can cause xe2x80x9cindentionxe2x80x9d and pressure injury, particularly in patients with sever edema. Waffle boots have the additional disadvantage in that they cannot be adjusted to rotate pressure points on the calf and foot areas. Furthermore, after periods of time as little as 1 hour the foam in waffle boots can compress so the heel is no longer relieved of pressure, and, in fact, is in a pocket of increased pressure.
Because the present invention has minimal elevation and does not restrain the movement of the patient, it is especially suitable for use with patients having arterial disease. It avoids the pain associated with slings and other means of limb elevation in such patients. The present invention allows the patient to continue to have minimal unconstricted movement of the extremity, which provides increased comfort with no decrease in blood flow.
The use of high density foam in the present invention allows positioning of the patient at the recommended elevation of approximately 1 inch with support of the calf and knee. The average hospital pillow is not made of high density foam and is not suitable for this use. On the contrary, the average hospital pillow compresses under extremity pressure and does not keep the heel or upper extremity off the bed for extended periods of time.
The standard hospital wedge type pillow does not provide for the proper positioning of the present invention. A wedge type pillow is intended for upper torso elevation, and can constrict the knee area, which decreases circulation to the foot and calf area, causing discomfort and possible injury.
The object of this invention is to provide a support used to prevent development of heel and foot pressure ulcers in patients confined to bed.
Another objective is to provide a support with a waterproof coating which resists infiltration by wound exudate and allows easy cleaning of the cushion.
Another objective is to provide a support which elevates the legs with respect to the torso in order to improve circulation in the legs and feet.
Another objective is to provide a support which suspends the heels and feet without contact with a support surface to prevent the development of pressure ulcers or facilitate the management of existing pressure ulcers.
Another objective is to provide a support which prevents the patient""s legs from falling from the edges of the cushion while allowing normal movement of the legs associated with patient management.
Another objective is to provide a support with an inlay of specialized support surface for patients at unusual risk of development of pressure ulcers in the lower extremities.
Another objective is to provide a support with a scalloped surface for accommodations of the lower extremities in patients where it is desirable to suppress movement of the lower extremities.
Another objective is to provide a support which can be packaged in a reduced volume in order to relieve the storage requirement for cushion inventory.
A final objective is to provide a support which is inexpensive, easy to manufacture, and capable of manufacture and use without adverse effect on the environment.